MA52756B1 - Compositions pharmaceutiques stables pour inhalateurs doseurs sous pression - Google Patents

Compositions pharmaceutiques stables pour inhalateurs doseurs sous pression

Info

Publication number
MA52756B1
MA52756B1 MA52756A MA52756A MA52756B1 MA 52756 B1 MA52756 B1 MA 52756B1 MA 52756 A MA52756 A MA 52756A MA 52756 A MA52756 A MA 52756A MA 52756 B1 MA52756 B1 MA 52756B1
Authority
MA
Morocco
Prior art keywords
dose
stable pharmaceutical
pharmaceutical composition
pharmaceutical compositions
pressurized
Prior art date
Application number
MA52756A
Other languages
English (en)
Other versions
MA52756A (fr
Inventor
Mukul Dalvi
Abhishek Gupta
Agnes Colombani
Original Assignee
Lupin Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lupin Inc. filed Critical Lupin Inc.
Publication of MA52756A publication Critical patent/MA52756A/fr
Publication of MA52756B1 publication Critical patent/MA52756B1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/401—Proline; Derivatives thereof, e.g. captopril
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4748—Quinolines; Isoquinolines forming part of bridged ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une composition pharmaceutique stable destinée à être utilisée avec des inhalateurs doseurs sous pression et comprenant un agoniste β2, un agent propulseur, un co-solvant, un ou plusieurs acides organiques et éventuellement de l'eau. L'invention concerne en outre une composition pharmaceutique stable comprenant un agoniste β2, un corticostéroïde inhalé et/ou un antagoniste muscarinique à action prolongée. L'invention concerne également une composition pharmaceutique pour le traitement ou la prophylaxie de l'asthme, de la bronchopneumopathie chronique obstructive (BPCO), de la rhinite ou en tant que thérapie complémentaire pour la fibrose kystique, la bronchectasie à fibrose non kystique, les infections pulmonaires ou la fibrose pulmonaire.
MA52756A 2018-06-04 2019-06-04 Compositions pharmaceutiques stables pour inhalateurs doseurs sous pression MA52756B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862680173P 2018-06-04 2018-06-04
EP19732190.4A EP3801457B1 (fr) 2018-06-04 2019-06-04 Compositions pharmaceutiques stables pour inhalateurs doseurs sous pression
PCT/US2019/035362 WO2019236559A1 (fr) 2018-06-04 2019-06-04 Compositions pharmaceutiques stables pour inhalateurs doseurs sous pression

Publications (2)

Publication Number Publication Date
MA52756A MA52756A (fr) 2021-04-14
MA52756B1 true MA52756B1 (fr) 2026-07-31

Family

ID=66998507

Family Applications (1)

Application Number Title Priority Date Filing Date
MA52756A MA52756B1 (fr) 2018-06-04 2019-06-04 Compositions pharmaceutiques stables pour inhalateurs doseurs sous pression

Country Status (13)

Country Link
US (1) US20210315842A1 (fr)
EP (1) EP3801457B1 (fr)
AU (1) AU2019282562A1 (fr)
DK (1) DK3801457T3 (fr)
EA (1) EA202092976A1 (fr)
ES (1) ES3075307T3 (fr)
FI (1) FI3801457T3 (fr)
JO (1) JOP20200314A1 (fr)
LT (1) LT3801457T (fr)
MA (1) MA52756B1 (fr)
PT (1) PT3801457T (fr)
WO (1) WO2019236559A1 (fr)
ZA (1) ZA202007890B (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220040086A1 (en) * 2018-10-01 2022-02-10 Kindeva Drug Delivery L.P. Formulation and aerosol canisters, inhalers, and the like containing the formulation
US20230080276A1 (en) 2020-02-20 2023-03-16 Chiesi Farmaceutici S.P.A. Pressurised metered dose inhalers comprising a buffered pharmaceutical formulation
GB2614901B (en) 2022-01-21 2026-07-29 Nanopharm Ltd Inhalable formulations
AU2023275947A1 (en) 2022-05-27 2025-01-16 Chiesi Farmaceutici S.P.A. A pharmaceutical formulation for pressurised metered dose inhaler
JP2025517808A (ja) 2022-05-27 2025-06-10 キエシ・フアルマチエウテイチ・ソチエタ・ペル・アチオニ 加圧式定量噴霧吸入器のための医薬製剤
US20240252475A1 (en) * 2023-01-26 2024-08-01 Somerset Therapeutics, Llc Tiotropium combination product compositions and related methods
WO2026006658A1 (fr) 2024-06-27 2026-01-02 Lupin Inc. Compositions pharmaceutiques stables pour inhalateurs doseurs sous pression

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EE05167B1 (et) 2000-05-22 2009-06-15 Chiesi Farmaceutici S.P.A. Stabiilsed farmatseutilised lahuspreparaadid survestatud doseerivatele inhalaatoritele
US20060257324A1 (en) 2000-05-22 2006-11-16 Chiesi Farmaceutici S.P.A. Pharmaceutical solution formulations for pressurised metered dose inhalers
EP1531866A1 (fr) * 2002-08-29 2005-05-25 Cipla Ltd. Produits et compositions pharmaceutiques comprenant des agents anticholinergiques specifiques, des agonistes beta-2 et des corticosteroides
TWI359675B (en) 2003-07-10 2012-03-11 Dey L P Bronchodilating β-agonist compositions
US20060140873A1 (en) 2004-12-27 2006-06-29 Chang Heng W Aerosol pharmaceutical compositions
WO2007020204A2 (fr) * 2005-08-12 2007-02-22 Boehringer Ingelheim Pharma Gmbh & Co. Kg Formulations d'hydrofluorocarbone en solution contenant du chlorhydrate de salbutamol ou du citrate de salbutamol
EP1982709A1 (fr) * 2007-04-19 2008-10-22 CHIESI FARMACEUTICI S.p.A. Utilisation d'une composition comportant du formotérol et du dipropionate de béclométhasone pour la prévention ou le traitement d'une condition aiguë de l'asthme
HRP20140582T4 (hr) * 2009-12-23 2023-06-09 Chiesi Farmaceutici S.P.A. Kombinacijska terapija za copd
MX2013000642A (es) * 2010-07-16 2013-04-03 Cipla Ltd Composiciones farmaceuticas.
KR20180028563A (ko) * 2010-10-12 2018-03-16 시플라 리미티드 약학 조성물
US20120204871A1 (en) * 2011-02-10 2012-08-16 Julio Cesar Vega Stable, non-corrosive formulations for pressurized metered dose inhalers
WO2012110770A2 (fr) * 2011-02-17 2012-08-23 Cipla Limited Composition pharmaceutique
GB2545025A (en) * 2015-12-04 2017-06-07 Mexichem Fluor Sa De Cv Pharmaceutical composition

Also Published As

Publication number Publication date
PT3801457T (pt) 2026-07-22
ZA202007890B (en) 2022-06-29
AU2019282562A1 (en) 2021-01-21
FI3801457T3 (fi) 2026-07-13
JOP20200314A1 (ar) 2020-12-06
WO2019236559A1 (fr) 2019-12-12
EP3801457B1 (fr) 2026-05-20
US20210315842A1 (en) 2021-10-14
EP3801457A1 (fr) 2021-04-14
EA202092976A1 (ru) 2021-03-16
DK3801457T3 (da) 2026-07-06
MA52756A (fr) 2021-04-14
ES3075307T3 (en) 2026-08-03
LT3801457T (lt) 2026-08-10